La Jolla Pharmaceutical Company (LJPC +14.5%) is up on modest volume in early trade on the heels of positive interim data from a Phase 2 clinical trialevaluating LJPC-401 (synthetic human hepcidin) in patients with hereditary hemochromatosis, a disorder caused by the excessive absorption of iron from the diet that can lead to tissue and organ damage.
The primary endpoint is the change in blood iron levels at week 16 as measured by a laboratory test called transferrin saturation (TSAT).
Preliminary results on 26 patients who completed the 16-week treatment period (12 – treated, 14 – placebo) showed an average reduction in TSAT of 42% compared to an average reduction of 6% in the control group, a statistically significant separation (p<0.0001).
There were only three phlebotomy procedures (blood draws) in two treated patients versus 24 in nine patients in the placebo group.
On the safety front, the most frequent treatment-emergent adverse event was injection site reaction (79%), all mild or moderate.
Topline results should be available in H2.
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